Patent application title: HYALURONIC ACID PRODUCT AND METHOD FOR TREATING LACERATIONS AND WOUNDS IN A LIVING BODY

Abstract:

A method for texturing the surface of a breast implant includes the step
of partially impregnating a silicone outer surface of the implant with
particles of a biologically active material such as acellular dermis of
human or animal origin and/or hyaluronic acid granules. The biologically
active material promotes tissue ingrowth into a plurality of cavities
filled with a biologically active material.

Claims:

1. A method for treating lacerations and wounds in a living human body
comprising the steps of:providing a first mass of a preservative free
hyaluronic acid and a second mass of a human compatible oil;reducing the
particle size of the hyaluronic acid to produce ultra-fine particles of
hyaluronic acid;forming an emulsion of the fine particles in the human
compatible oil;applying the emulsion to the laceration or wound of the
patient; andforming an hyaluronic acid gel by applying water to the
emulsion on the laceration or wound of the patient.

2. A method for treating lacerations and wounds in a human body according
to claim 1 in which the human compatible oil is rapidly absorbable into
the skin of a patient.

3. A method for treating lacerations and wounds in a human body according
to claim 2 in which the human compatible highly absorbable oil is
squalane oil.

4. A method for treating lacerations and wounds in a human body according
to claim 3 in which the hyaluronic acid consists of pure hyaluronic acid.

5. A method for treating lacerations and wounds in a human body according
to claim 4 in which the hyaluronic acid particles have a particle size of
less than about 70 microns.

6. A method for treating lacerations and wounds in a human body according
to claim 4 in which the hyaluronic acid particles have a particle size of
about 20 microns or less.

7. A method for treating lacerations and wounds in a human body according
to claim 6 in which the hyaluronic acid gel is formed by spraying water
onto the emulsion.

8. A method for treating lacerations and wounds in a human body according
to claim 7 in which the emulsion contains between about 5% and about 20%
by weight hyaluronic acid and in which between 95% and 80% by weight
squalane oil.

9. A hyaluronic acid product for treating lacerations and wounds in a
living body comprising an emulsion of hyaluronic acid in a human
compatible highly absorbable oil.

10. A hyaluronic acid product for treating laceration and wounds in a
living body according to claim 9 in which the human compatible highly
absorbable oil is squalane oil.

11. A hyaluronic acid product for treating laceration and wounds in a
living body according to claim 10 wherein the preparation contains about
5 to about 20% by weight hyaluronic acid and about 95% to about 80% by
weight squalane oil.

12. A hyaluronic acid product for treating laceration and wounds in a
living body according to claim 11 in which the hyaluronic acid in the
emulsion has a particle size of less than about 70 microns.

13. A hyaluronic acid product for treating laceration and wounds in a
human body according to claim 12 in which the hyaluronic acid in the
emulsion has a particle size of 20 microns or less.

14. A method for preparing a hyaluronic acid product according to claim 14
in which the particle size of the hyaluronic acid is reduced to about 20
microns or less.

15. A method for preparing a hyaluronic acid product according to claim 15
wherein the product contains from 5-20% by weight hyaluronic acid and
between about 95-80% by weight squalane oil.

Description:

FIELD OF THE INVENTION

[0001]This invention relates to a hyaluronic acid product and method for
treating lacerations and wounds in a living body and more particularly to
a hyaluronic acid gel and method for applying hyaluronic acid gel to
wounds or abraded skin in a preservative free form.

BACKGROUND FOR THE INVENTION

[0002]It is known that hyaluronic acid (HA) provides a favorable
environment for cell growth and motility that may foster tissue
regeneration instead of fibrosis. This observation may have therapeutic
implications in that HA applications may modulate healing of adult wounds
in a manner more similar to the manner of fetal wound healing. These
facts and observations were reported in an article entitled "Using
Hyaluronic Acid to Create a Fetal-like Environment In Vitro by Scott
Shepard, Hilton Becker and James Hartmann that was published in the
Annals of Plastic Surgery, Volume 36, No. 1 January 1996. The article
went on to state: "Our study shows that the closure of a mechanical
disruption (in vitro wound) of this type is accelerated by the addition
of exogenous HA in the presence of adult serum . . . ." These findings
suggest that large amounts of HA enhance the proliferation of fibroblasts
from dermal tissue and promote the phenotypic changes associated with the
migration of fibroblasts into a wound.

[0003]Hyaluronic acid gel is a naturally occurring disaachoride found in
the skin and joints. It has been shown to have a stimulatory effect on
cell division thus accelerating healing. HA is water solvable. However,
once dissolved in water, due to its high nutritive value, it is rapidly
prone to bacterial contamination and ingrowth. Therefore, preservatives
must be added to prevent bacterial growth. This growth inhibiting effect
is undesirable for the healing of wounds or abraded skin.

[0004]Squalane oil is a botanical lipid that duplicates the molecular
structure and weight of human lipids. Scientists have found that the
skin's sebaceous glands synthesize approximately 10-12% Squalane.
However, today most Squalane oil is derived from plants as opposed to the
animal derived (shark liver oil). It has been found that the valuable
lipid produced from olives is extremely compatible with the skin and
safe. It has also been found that Squalane oil permeates into the skin at
a rate of 2 mm/second.

[0005]Increasing use of hyaluronic acid in cosmetic and other surgery has
lead to an increase in the use of hyaluronic acid gel to speed up healing
and reduce scarring. Accordingly, it is presently believed that there is
a need for a relatively pure hyaluronic acid that is free of
preservatives and at the same time free of harmful bacteria. It is also
believed that there is a relatively large market for any such product. It
is also believed that the hyaluronic products in accordance with the
present invention are free of preservatives and at the same time enhance
healing of lacerations and wounds in the human body.

BRIEF SUMMARY OF THE INVENTION

[0006]In essence, the present invention contemplates a water activatable
medicinal preparation for treating lacerations and wounds in a human
body. The medicinal preparation is an emulsion of finely ground
hyaluronic acid dispersed in a human compatible oil and preferably in a
human compatible absorbable oil such as Squalane oil. In a preferred
embodiment of the invention the emulsion contains about 5% to about 20%
hyaluronic acid by weight or by volume. In a more preferred embodiment of
the invention the particles size of the hyaluronic acid is equal to or
less than about 20 microns.

[0007]The present invention also contemplates a method for treating
lacerations and wounds in a living body such as a human being in order to
enhance healing and reduce scarring. The method includes the steps of
providing a water activatable emulsion of relatively pure hyaluronic acid
in a human compatible and preferably highly absorbable oil. The
hyaluronic acid is preferably ground to a fine particle size of about 20
microns or less and mixed into a dispersion in the human compatible
absorbable oil to produce an emulsion with about 5% to about 20% by
weight or volume hyaluronic acid. The emulsion is then applied to the
laceration or wound by any means as will be well understood by a doctor
or surgeon of ordinary skill in the art and activated with water to form
hyaluronic acid gel. Typically the application of water may be by a fine
spray but, other methods may be used. The oil is absorbed by the body
while a portion of the water additives remain in contact with the
hyaluronic acid and forms a hyaluronic acid gel which enhances the
healing of the laceration and/or wound.

[0008]The invention will now be described in connection with the
accompanying figures.

DESCRIPTION OF THE DRAWINGS

[0009]FIG. 1 is a flow chart illustrating the formation of a water
activated emulsion for treating human injuries namely lacerations and
wounds and a method for treating lacerations and wounds with a water
activatable emulsion;

[0011]FIG. 3 is a photograph of the wound shown in FIG. 2 with the
application of Hyaluronic Acid/Oil;

[0012]FIG. 4 is a photograph of the wound shown in FIGS. 2 and 3 after
spraying with water to form a gel;

[0013]FIG. 5 is a photograph of the wound shown in FIGS. 2-4 but covered
with the gel formed in FIG. 4; and

[0014]FIG. 6 is a photograph of the wound shown in FIGS. 2-5 after healing
for 10 days.

DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION

[0015]FIG. 1 illustrates a first embodiment of the invention i.e. a method
for treating lacerations or wounds in a living body. The method includes
the step 20 of providing a first mass of a preservative free hyaluronic
acid in relatively pure form and a second mass of a human compatible and
prefereably absorbable oil as for example Squalane oil.

[0016]Hyaluronic acid is a glycosaminoglycan (GAG) and is present in
cartilage as a coating around each cell and is also found in skin and
other tissues. Hyaluronic acid helps wounds to heal more quickly and can
reduce the appearance of scars. Medical grade hyaluronic acid is
available in average particle sizes ranging from about 20 to about 700
microns.

[0017]In the practice of the present invention, it is believed that the
smaller the particle size of the hyaluronic acid, the better the result.
Accordingly, it is presently believed that the 20 micron particles size
can be further reduced by grinding. Samples of larger particles were also
reduced by grinding or on a small scale with a mortar and pestle. Thus,
the second step 24 in the present invention includes reducing the
hyaluronic acid particles to about 20 microns and preferably to about 20
microns or less.

[0018]Squalane oil is a botanical lipid derived from olives, has a
molecular formula of C30H62 and permeates into the skin of a
human at a rate of 2 mm/sec. Squalane oil is human compatible, rapidly
absorbed into the body and because of the deep penetration assists in the
acceleration of cell growth. It is believed that other human compatible
oils may be used in the practice of the invention, however absorbable
oils and preferably highly absorbable oils are preferred.

[0019]In step 26, the finely ground hyaluronic acid is thoroughly mixed
with the human compatible highly absorbable oil to form an emulsion i.e.
a mixture of two immiscible (unblendable) substances. One substance (the
dispersed phase) is dispersed in the other (the continuous phase). The
resulting mix may also be defined as a dispersion wherein the dispersed
phase is suspended in a dispersion medium. The mixing maybe by
conventional means. The resulting mix can also be defined as a suspension
wherein microscopically visible particles are dispersed throughout a less
dense liquid where they are easily filtered out, but not easily settled.

[0020]The emulsion of hyaluronic acid particles in a human compatible
absorbable oil is applied to a wound or laceration in step 28. This
application is done in a conventional manner as will be well understood
by persons of ordinary skill in the art such a surgeons and more
particularly cosmetic surgeons.

[0021]In step 30 a cosmetic surgeon applies water to the emulsion as for
example by a fine spray or other means. It is presently believed that the
absorbable oil rapidly penetrates the skin leaving a portion of the
hyaluronic acid particles on the surface and that the water reacts with
the hyaluronic acid particle to form a hyaluronic acid gel at the wound
site or on the laceration as well as into the dermis. It is also believed
that a portion of the hyaluronic acid gel is carried into the patient's
dermis while a portion covers the wound area to enhance healing.

[0022]A further advantage of a highly absorbable oil such as Squalane oil
is that it leaves little or no oily residue at the surface.

[0023]A hyaluronic acid product in accordance with the present invention
comprises an emulsion, dispersion or suspension of relatively fine
preservative free hyaluronic acid particles of less than about 70 microns
and preferably less than about 20 microns in a rapidly absorbable human
compatible oil. The product is prepared as discussed above and is
activatible by the application of water to a coating or thin film of the
product on a patient's wound. In the preferred embodiment of the
invention the emulsion contains between 5-20% hyaluronic acid and 95% to
about 80% of Squalane oil wherein the percentage given is percent by
weight and/or approximately the same percentage by volume.

[0024]While the invention has been described in connection with its
preferred embodiments it should be recognized that changes and
modifications may be made therein without departing from the scope of the
appended claims.